[11C]Acetate PET in Patients With Glioma

NCT02986815 | Terminated DMC

• 1 other identifier: STU 052016-034
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

At each point that the patient will have \[11C\]-Acetate PET study, this will be compared with standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide (chemotherapy) Quantitative Image Data Analysis: The \[11C\]-Acetate uptake in tumor sites from images will be analyzed qualitatively by visual assessment, quantitatively using a standard uptake value (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by compartmental modeling of dynamic data.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas

  Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.

  Every 3 months for 24 months

Secondary Outcomes (3)

• Decrease in [11C]Acetate uptake following treatment of grade 2 glioma

  Every 3 months for 24 months

• Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma

  Every 3 months for 24 months

• Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas

  Every 3 months for 24 months

Study Arms (1)

[11C]Acetate Brain Imaging

EXPERIMENTAL

\[11C\]Acetate will be administered The patient will have one intravenous line placed prior to \[11C\]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which \[11C\]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure.

Other: [11C]Acetate Brain Imaging

Interventions

[11C]Acetate Brain Imaging OTHER

Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the \[11C\]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.

[11C]Acetate Brain Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 and older, of any ethnic group
• Spanish-speaking patients will be eligible
• Histological diagnosis of glioma or
• Brain MR imaging suggestive of a glioma or 2HG \> 2mM by MR spectroscopy in patients who have not had a surgical procedure to establish the diagnosis.
• Karnofsky Performance status \> 70%
• Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
• Patient able and willing to provide informed consent

You may not qualify if:

• Patient or legal parent/guardian unable to provide informed consent
• Psychiatric or addictive disorders that preclude obtaining informed consent
• Karnofsky Performance status \< 70%
• NYHA class III and IV congestive heart failure
• Unstable angina
• Pregnant or lactating women
• Women of childbearing potential who refuse a pregnancy test

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75063, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 8, 2016
• Study Start: January 24, 2017
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)